OpenLegislation

Paragraph 1

United Kingdom

(1)

Subject to the following sub-paragraphs, where the United Kingdom Ethics Committee Authority (“the Authority”) receive a notice pursuant to F1regulation 24(3) that a F2sponsor wishes to appeal against an ethics committee opinion which is not favourable, the Authority shall, subject to sub-paragraph (2)—

(a)

direct that the application for that opinion may be considered by another ethics committee specified in the direction; F3...

(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2)

F4... The Authority may refuse to give a direction F5... pursuant to sub-paragraph (1) where it considers that the grounds for appealing against the opinion are unfounded.

(3)

Where the Authority refuse to give a direction F6... pursuant to sub-paragraph (1), the Authority shall send a notice to the F7sponsor setting out their reasons for refusal.

F8(4)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations

Textual amendments

F1

Words in Sch. 4 para. 1(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(a)(i)

F2

Word in Sch. 4 para. 1(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(a)(ii)

F3

Sch. 4 para. 1(1)(b) and word omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(a)(iii)

F4

Words in Sch. 4 para. 1(2) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(b)(i)

F5

Words in Sch. 4 para. 1(2) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(b)(ii)

F6

Words in Sch. 4 para. 1(3) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(c)(i)

F7

Word in Sch. 4 para. 1(3) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(c)(ii)

F8

Sch. 4 para. 1(4) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(d)